FDA label 403fe2cc-75db-4bb2-9530-5cf19677fc29

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID: 1c1f930b-6b64-4af3-8310-b1d598f70be0
SPL ID: 403fe2cc-75db-4bb2-9530-5cf19677fc29
Version: 3
Effective date: 2016-06-13
Source export date: 2026-09-28
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:31:00

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		403fe2cc-75db-4bb2-9530-5cf19677fc29	id
spl set id		1c1f930b-6b64-4af3-8310-b1d598f70be0	set_id

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings If symptoms worsen, or redness or skin irritation occurs, discontinue product. Some individuals may be sensitive to tea tree or other oils. Begin with a small drop to determine if the product causes any increased redness or irritation and discontinue use if it irritates your skin. If you are pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. If accidental ingestion, get medical help or contact a Poison Control Center. For external use only. Do not apply to the eyes or mucous membranes. Keep all medicines out of the reach of children.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.